sorin 3T - Operational Safety

Heater-Cooler System 3T • Safety
2.4 CP_IFU_16-XX-XX_USA_015
2.2.4 Operational safety
◗ Prior to working with the heater-cooler, the user must have thoroughly read the operating
instructions and have become familiar with the device functions!
◗ Ensure that the heater-cooler is placed on a horizontal surface and the castor brakes have been
locked prior to operation.
◗ Pay attention to hand hygiene and protective barriers by disinfecting your hands and using
disposable gloves prior to connecting tubing or filling the tanks.
◗ Use filtered tap water that has been filtered by using e.g. a disposable Pall-Aquasafe water filter
with an 0.2 µm membrane (Pall part reference in the U.S.: “AQINA”; “AQIN” in other countries).
Alternatively, use a filter of equivalent performance that meets the requirements for bacterial
retention according to the ASTM standard*, i.e. which retains Brevundimonas diminuta to
≥10
7
CFU/cm
2
of effective filtration area.
* (American Standard Test Method F838-05 “Determining Bacteria Retention of Membrane Filters Utilized for Liquid
Filtration”)
◗ If available, use demineralized tap water.
◗ Check the water level of the tanks prior to each operation. Only operate the heater-cooler, if the
water level is sufficient, i.e., is above the minimum water level (one segment of the bar graph
display).
!
◗ Prior to operation, check all cables, tubings, connectors and other accessories in view of correct
connections, leaks and proper function. Replace all damaged components at once.
◗ Check the actual temperature displays on the heater-cooler regularly.
!
◗ Check the patient’s blood temperature and the temperature of the cardioplegic solution with an
appropriate temperature measurement system regularly, independent of the displays on the
heater-cooler (e.g. at the HLM).
!
◗ For emergencies, e.g. in case of a total failure, ensure that a replacement with compatible
connectors is ready for operation.
◗ Activate the pumps of the primed and filled system prior to its first operation. Watch the water level
display on the heater-cooler control panel and monitor the connected heat exchanger (e.g.
oxygenator, heating/cooling blanket). A leakage in a water circuit will influence the water level in
the connected tank.
◗ Do not use self-closing tubing connectors. Compared to “open” connectors, self-closing
connectors reduce the water flow.
◗ Ensure that the cables and tubings are laid out as straightly as possible and do not kink or twist
them. Kinked or twisted cables or tubings could pose a hazard for personnel (who could stumble,
or get caught on the tubing).
◗ A primed and filled heater-cooler must not exceed a total weight of 125 kg (275.5 lbs.).